...502 (f) (1) of the act if it complies with all of the following conditions: (1) Such drug or device, 3 j^^3`6Yh > $ ( > ` ;]= , l{ נͺ W )v w < Q ... %aR m e X Y r׽ M |1 F pdZ*̡ Ǜ RE+ C generally recognized among experts qualified by scientific training and experience to evaluate its...

...use by man which— (A) is a habit-forming drug to which section 352(d) of this title applies; or (B) because of its toxicity or other potentiality for...except under the supervision of a practitioner licensed by law to administer such drug; or (C) is limited by an approved application under section 355 of this...

...such requirements are not necessary for the protection of the public health by reason of the drug's toxicity or other potentiality for harmful effect,...use, or the collateral measures necessary to its use, and he finds that the drug is safe and effective for use in self -medication as directed in proposed...

...Exemptions From Adequate Directions for Use § 801.109 Prescription devices. A device which, because of any potentiality for harmful effect, or the method of...collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and...

...not necessary for the protection of the public health by reason of the 12 §310.201 drug's toxiclty or other potentiality for harmful effect, or the method...use, or the collateral measures necessary to its use, and he finds that the drug is safe and effective for use in self-medication as directed in proposed...

...requirements are not necessary for the protection of the public health by reason of the drug's toxlclty or other potentiality for harmful effect, or the method...or the collateral measures nec-essary to its use, and he finds that the drug 1 is safe and effective for use in self-medication as directed in proposed...

...necessary for the protection of the public health by reason of the §310.103 §310.201 drug's toxlcity or other potentiality for harmful effect, or the method...use, or the collateral measures necessary to its use, and he finds that the dru? is safe and effective for use in self-medication as directed in proposed...

...of such labeling. § 201.105 Veterinary drugs. A drug intended for veterinary use which, because of toxicity or other potentiality for harmful effect, or the method of its use, is not safe for animal use except under the supervision of a licensed veterinarian, and hence for which...

...25777. Apr. 15, 1980] § 201.105 Veterinary drugs. A drug intended for veterinary use which, because of toxicity or other potentiality for harmful effect, or the method of its use, is not safe for animal use except under the supervision of a licensed veterinarian, and hence for which...

...not indicate safety concerns about the condition's toxicity or other potentiality for harmful effect, the method of its use, or the collateral measures necessary to its use. (2) The condition must have been marketed OTC for a minimum of 5 continuous years in the same country...